The European Commission s science and knowledge service
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1 The European Commission s science and knowledge service Joint Research Centre Directorate-General Joint Research Centre Directorate-General Health and Food Safety Knowledge generation centre for rare diseases Ciaran Ciaran Nicholl / Simona Martin Joint Research Centre, Directorate F Health, Consumers and Reference Materials Unit F.1 Health in Society 1
2 Why an EU Platform on RD Registration? To cope with the extreme fragmentation of data sources across EU Member States Many RD registries exist, but Benefits: Reach the critical number of patients for studies (epidemiological, clinical, translational, pharmacolgical, etc.) research - the lack of interoperability severely limits the registries' potential - no standardised data collection for most RDs Source: EURORDIS Functions DATA REPOSITORY 2
3 European Rare Disease Registry Infrastructure FIRST WORKSHOP Registry-related projects RD-JA Orphanet EUCERD-JA RD-CONNECT Workpackage "Registries", University of Frankfurt EPIRARE IRDiRC PARENT EURORDIS EXPAND Recommendations of EC Expert Group RD 3
4 TOOLS European Directory of Registries.dor.dor The European Directory of RD registries List of participating RD registries CORE COMPONENT OF / EU RD PLATFORM Descriptive information - specific rare disease addressed - scope - operating institution - contact information, etc.). = characteristics of registries (27) 4
5 TOOLS European Directory of Registries.dor Metadata Repository.mdr European RD Registry Infrastructure ().mdr The Metadata Repository Semantic interoperability Metadata Repository.mdr = collection of metadata on all data elements collected by participating registries Designation Definition Measurement unit + range Consequence: use of common definitions for data elements terms are understood in the same way by all data providers + data users.mdr = thesaurus of terms used by participating registries common format 5
6 EU Rare Diseases Registry Infrastructure Metadata Repository European Directory of Registries Directory of Registries Registry 1 Registry 2 Registry 3 TOOLS Metadata Repository European Directory of Registries Pseudonymisation tool Collaboration with Austrian Institute of Technology 6
7 Metadata Repository Search Broker Data Warehouse European Directory of Registries Search Broker Pseudonymisation tool Reporting Data Set Common Data Set Registries European Rare Disease Registry Infrastructure PROVIDES the infrastructure and tools To make registries' data SEARCHABLE FINDABLE interoperable reusable If accessible it depends on the data owner! 7
8 EU standards Set of Common Data Elements for RD Registration infrastructure/tools EU standards Training JRC Training Workshop - MDR, DoR - session 1 February session 2 March 2018 JRC Training Workshop pseudonymisation - March
9 Functions DATA REPOSITORY infrastructure/tools EU standards Training European RD Registry data warehouse European surveillance networks JRC- EUROCAT Registry Database JRC- SCPE Registry Database Integration with other healthrelated databases Omics Biobanks 9
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